NOVOLOG

Product NDC: 50090-1678
Requested package NDC: 50090-1678-0
11-digit product format: 500901678
Labeler code: 50090
Product ID: 50090-1678_b01617ba-efae-44d9-b8ce-15a977d2fed5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin aspart
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA020986
Marketing category: BLA
Marketing start: 2003-01-22
Substance: INSULIN ASPART
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: NOVOLOG
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INSULIN ASPART	100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D933668QVX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311040	Internal RxNorm lookup
351926	Internal RxNorm lookup
1653196	Internal RxNorm lookup
1653198	Internal RxNorm lookup
1653202	Internal RxNorm lookup
1653204	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e172b4f8-9b25-4019-8e09-afc10b2f30c9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
24eab60a-55c8-40c1-8c86-7ed01a7a8bef	Product name	1	20240227
09fb02dd-baf0-4f67-b464-599bf26324b6	Product name	2	20200323
6a6ef80c-37d6-4e02-aa78-fce7b811234e	Product name	2	20200323
91ae268d-ee0f-6988-629d-5065a4376a50	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1678-0	NOVOLOG	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3		28
50090-1678-0	NOVOLOG	5 in 1 CARTON	INJECTION, SOLUTION	5		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1678-0	ML - Milliliter	50090-1678	bc53111b-35aa-4c73-869d-97f94a44aaa1	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1678	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	28	Current NDC, Legacy NDC, 2 package rows	20231210_e172b4f8-9b25-4019-8e09-afc10b2f30c9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Aspart	INSULIN ASPART	REMEDYREPACK INC.	b3d77cb0-cd47-441f-8f54-5329c655da9c	2026-01-14	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Aspart	INSULIN ASPART	A-S Medication Solutions	c3e4c46e-5211-4f05-b7ab-1e9ad270876b	2024-09-11	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Aspart	INSULIN ASPART	A-S Medication Solutions	bfd2b192-35e5-4773-ab73-802565b2ad78	2024-03-14	Warnings, Adverse reactions	Exact identifier application number: BLA020986
NOVOLOG	INSULIN ASPART	A-S Medication Solutions	13891e5a-e57a-46e8-911c-2f680352b52b	2023-12-15	Warnings, Adverse reactions	Exact identifier application number: BLA020986
NOVOLOG	INSULIN ASPART	A-S Medication Solutions	e172b4f8-9b25-4019-8e09-afc10b2f30c9	2023-12-09	Warnings, Adverse reactions	Exact identifier application number: BLA020986 ndc (package): 50090-1678-0 ndc (product): 50090-1678 ndc11 (package): 50090167800
Insulin Aspart	INSULIN ASPART	Novo Nordisk Pharma, Inc.	bee5b358-c863-420b-be73-ced2e920c499	2023-02-28	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Diluting Medium for NovoLog	WATER INJECTION	Novo Nordisk	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	2023-02-28	Warnings, Adverse reactions	Exact identifier application number: BLA020986

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020986	Novolog	insulin aspart	351(a)	Rx	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D933668QVX	INSULIN ASPART	116094-23-6	INSULIN ASPART

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1653196	insulin aspart 100 UNT/ML in 3 ML Cartridge	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	insulin aspart 100 UNT/ML in 3 ML Pen Injector	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin aspart 100 UNT/ML Injectable Solution	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	NovoLOG 100 UNT/ML in 3 ML Cartridge	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLOG 100 UNT/ML in 3 ML Pen Injector	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	NovoLOG 100 UNT/ML Injectable Solution	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653196	3 ML insulin aspart, human 100 UNT/ML Cartridge	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	3 ML insulin aspart, human 100 UNT/ML Pen Injector	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin aspart, human 100 UNT/ML Injectable Solution	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	3 ML NovoLog 100 UNT/ML Cartridge	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	3 ML NovoLog 100 UNT/ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin analog, aspart 100 UNT/ML Injectable Solution	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653196	insulin, aspart, human 100 UNT/ML per 3 ML Cartridge	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	NovoLog 100 UNT/ML Injectable Solution	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1678-0	50090167800	5 SYRINGE, PLASTIC in 1 CARTON (50090-1678-0) / 3 mL in 1 SYRINGE, PLASTIC	2015-01-30	0000-00-00	No	No	Current